Data show continuous improvement in negative
symptoms, stable positive symptoms and extended safety profile
WALTHAM, Mass., Oct. 26, 2016 (GLOBE NEWSWIRE) --
Minerva Neurosciences, Inc. (NASDAQ:NERV), a clinical-stage
biopharmaceutical company focused on the development of therapies
to treat central nervous system (CNS) disorders, today announced
data from the 24-week open-label extension of its 12-week,
randomized, double-blind, placebo-controlled Phase IIb clinical
trial of MIN-101 as monotherapy in patients with negative symptoms
of schizophrenia. Data from the 12-week core phase of this trial
were reported in May of this year.
Graphic representations of the data summarized
below are available
at http://ir.minervaneurosciences.com/events.cfm and
contained in the Current Report on Form 8-K filed by Minerva on
October 26, 2016.
"Data from the extension phase demonstrate a
further and continuous improvement in negative symptoms in patients
with schizophrenia, as measured by the negative symptom subscales
of the Positive and Negative Syndrome Scale (PANSS)," said Dr. Remy
Luthringer, president and chief executive officer of Minerva. "The
longer patients were on monotherapy with MIN-101, the greater
improvement they were observed to experience in their negative
symptoms during the entire extension period, without evidence of
reaching a plateau. We believe that such continuous improvement in
symptoms over a nine month period in this patient population is
unprecedented.
"The data also provide an extended safety profile
for MIN-101 consistent with that observed during the core
double-blind phase of the trial," said Dr. Luthringer.
"MIN-101 was reported to be well tolerated at both doses over the
entire 36-week duration of the study by schizophrenic
patients. In addition, positive symptoms were observed to
remain stable through the extension period as measured by the PANSS
positive symptom subscale score. Improvements in overall
schizophrenic psychopathology were also observed, as measured by
the PANSS general psychopathology subscale and the total PANSS
score.
"We believe these exciting data point the way
toward pivotal testing of MIN-101 as a novel, differentiated
treatment for the large worldwide population of patients with
schizophrenia for whom negative symptoms contribute substantially
to poor quality of life and functional outcomes," said Dr.
Luthringer.
Results announced earlier this year from the
double-blind, placebo-controlled 12-week core phase of the trial
showed that it met its primary endpoint of statistically
significant improvement in negative symptoms as measured by the
PANSS pentagonal structure model (PSM), and showed statistically
significant benefit in multiple secondary endpoints that included
general psychopathology and cognition.
Patients who completed the core phase were
provided the opportunity to enter into a 24-week, open-label
extension phase. During the extension phase, all patients
received either 32 milligrams (mg) or 64 mg of
MIN-101. Patients who received placebo in the core phase
were randomized to one of these two doses at the beginning of the
extension phase. Data generated during the extension period
were intended to provide longer term supportive evidence of
efficacy and to complement the statistically significant results
obtained during the core phase.
One hundred forty-two patients from the treatment
and placebo groups in the core phase entered the extension phase,
with 88 patients completing the extension. Seventy
patients received 32 mg and 72 patients received 64 mg during the
extension.
Negative symptoms, assessed based on the PANSS
PSM, were observed to continue to improve during the extension
phase, as shown by a reduction from the study start for the 32 and
64 mg-treated groups of 5.5 points and 4.9 points, respectively,
and by a reduction of 5.4 points and 5.3 points, respectively, in
the PANSS three factors negative symptoms subscale.
Reductions over time of PANSS negative PSM scores are shown
in the attached graph.
http://www.globenewswire.com/NewsRoom/AttachmentNg/a29ffbc7-ffb5-4dd6-af4e-f042defb88d5
Positive symptoms were observed to remain stable
throughout the study, as measured by PANSS positive symptom scores.
This finding is consistent with the hypothesis that MIN-101 has a
direct and specific effect on negative symptoms.
General psychopathology was observed to improve
during the extension phase for the 32 and 64 mg groups, as shown by
reductions in the PANSS general psychopathology subscale score and
total PANSS score.
MIN-101 was generally reported to be well
tolerated through the entire 36-week period. QTcF, a
measurement of cardiac function, was closely monitored throughout
the study, and discontinuation criteria based on QTcF prolongation
were incorporated in the protocol. As previously announced,
two patients out of 162 who received MIN-101 in the core phase were
discontinued based upon these criteria; both of these patients
received the higher dose (64 mg). In the extension phase no
additional patients were discontinued. The extension data
also confirm that MIN-101 at the doses tested did not have an
effect on extra-pyramidal symptoms (EPS), prolactin or weight
gain.
About MIN-101
MIN-101 is a drug candidate with equipotent
affinities for sigma 2 and 5-hydroxytryptamine-2A
(5-HT2A) and lower
affinity at alpha1-adrenergic receptors. MIN-101 has no direct
dopaminergic post-synaptic blocking effects, known to be involved
in some side effects like extrapyramidal symptoms, sedation,
prolactin increases and weight gain.
About Schizophrenia and Negative
Symptoms
As described by the National Institute of Mental Health,
schizophrenia is a chronic and severe disorder that affects how a
person thinks, feels and acts1. In
2015 approximately 3.2 million people suffered from schizophrenia
in the U.S., Japan and the five major European markets.
Schizophrenic patients suffer from positive, negative and cognitive
symptoms. Negative symptoms are disruptions to normal
emotions and behaviors that may signal social withdrawal.
Patients may be socially inhibited, lack the ability to begin and
sustain planned activities, or speak little even when forced to
interact. Negative symptoms account for a substantial portion
of the morbidity associated with schizophrenia2.
They persist chronically throughout an individual patient's
lifetime and increase with severity over time.
About Minerva
Neurosciences
Minerva Neurosciences, Inc. is a clinical-stage
biopharmaceutical company focused on the development and
commercialization of a portfolio of products to treat CNS
diseases. Minerva's proprietary compounds include: MIN-101,
which recently completed a Phase IIb clinical trial for
schizophrenia; MIN-117, which recently completed a Phase IIa
clinical trial development for MDD; MIN-202 (JNJ-42847922),
which recently completed Phase IIa and Phase Ib clinical trials for
insomnia and MDD, respectively; and MIN-301, in pre-clinical
development for Parkinson's disease. Minerva's common stock
is listed on the NASDAQ Global Market under the symbol
"NERV." For more information, please
visit www.minervaneurosciences.com.
Forward-Looking
Safe Harbor Statement
This press release contains
forward-looking statements which are subject to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995,
as amended. Forward-looking statements are statements that
are not historical facts, reflect management's expectations as of
the date of this press release, and involve certain risks and
uncertainties. Forward-looking statements include statements
herein with respect to the timing and results of future clinical
milestones with MIN-101; the clinical and therapeutic potential of
MIN-101; our ability to successfully develop and commercialize
MIN-101; and management's ability to successfully achieve its
goals. These forward-looking statements are based on our
current expectations and may differ materially from actual results
due to a variety of factors including, without limitation, whether
MIN-101 will advance further in the clinical trials process and
whether and when, if at all, it will receive final approval from
the U.S. Food and Drug Administration or equivalent foreign
regulatory agencies and for which indications; whether the results
of future clinical trials of MIN-101, if any, will be consistent
with the results of past clinical trials; whether MIN-101 will be
successfully marketed if approved; whether our therapeutic product
discovery and development efforts with MIN-101 will be successful;
our ability to achieve the results contemplated by our
co-development agreements; management's ability to successfully
achieve its goals; our ability to raise additional capital to fund
our operations on terms acceptable to us; and general economic
conditions. These and other potential risks and uncertainties
that could cause actual results to differ from the results
predicted are more fully detailed under the caption "Risk Factors"
in our filings with the Securities and Exchange Commission,
including our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2016, filed with the Securities and
Exchange Commission on August 4, 2016. Copies of
reports filed with the SEC are posted on our website
at www.minervaneurosciences.com. The
forward-looking statements in this press release are based on
information available to us as of the date hereof, and we disclaim
any obligation to update any forward-looking statements, except as
required by law.
1 https://www.nimh.nih.gov/health/publications/schizophrenia-booklet-12-2015/index.shtml
2 Diagnostic
and Statistical Manual of Mental Disorders, Fifth Edition, American
Psychiatric Association.
Contact:
William B. Boni
VP, Investor Relations/
Corp. Communications
Minerva Neurosciences, Inc.
(617) 600-7376
This
announcement is distributed by Nasdaq Corporate Solutions on behalf
of Nasdaq Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Minerva Neurosciences, Inc. via Globenewswire
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